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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/17/2006
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device showed high impedance. X-rays were taken and showed that the lead pin may not be fully inserted into the generator header. The patient¿s parents elected to disabled the patient¿s device not and pursue surgery. The patient¿s seizure control did not change due to the disablement; however, it was noted that the patient may not have had any efficacy with vns prior to the event. No known surgical interventions have occurred to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4100841
Report Number1644487-2014-02381
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/20/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2007
Device MODEL Number102
Device LOT Number013476
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/22/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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